About 100 decongestant lawsuits claiming bogus ingredient tossed

By Diana Novak Jones

Nov 13 (Reuters) - A New York federal judge on Tuesday dismissed about 100 lawsuits that claimed Procter & Gamble PG.N, Haleon HLN.L and other companies knowingly marketed and sold over-the-counter medications containing a decongestant that didn’t work.

U.S. District Judge Brian Cogan in Brooklyn dismissed the lawsuits against medication manufacturers and grocery chains filed by consumers after a unanimous U.S. Food and Drug Administration advisory panel declared the decongestant, phenylephrine, ineffective in September 2023.

Cogan found that the companies were not obligated to update their labeling with new information about efficacy unless directed by the FDA. He also rejected the plaintiffs’ request that he hold off on dismissing the cases while the FDA considers whether to remove phenylephrine as an ingredient in over-the-counter cold medicines.

Attorneys for the plaintiffs did not immediately respond to requests for comment, nor did attorneys for Procter & Gamble, Haleon, Walgreens, Bayer and Johnson & Johnson’s former consumer business, all of which were facing claims in the litigation.

Lawsuits over phenylephrine began hitting the docket in September 2023, days after the FDA’s nonprescription drug advisory committee reviewed several studies and concluded that the ingredient, which was part of about 242 million products and generated $1.76 billion in sales in 2022, was essentially no better than a placebo.

The lawsuits claim the companies knew their phenylephrine products were ineffective as decongestants but still marketed and sold them to consumers.

The U.S. Judicial Panel on Multidistrict Litigation, which has tallied 99 phenylephrine lawsuits, centralized the claims in an MDL in New York federal court in December 2023. In June, the companies moved to dismiss a streamlined class action within the MDL that was brought on behalf of New York consumers, arguing that the consumers couldn’t rely on state law to challenge labeling that the companies were required to use under federal law. In October, Judge Cogan agreed with the companies and dismissed the New York case.

Tuesday’s ruling noted that the plaintiffs had agreed that a ruling on the New York motion to dismiss that addressed federal law's oversight of the drug labels would apply to the remainder of the cases in the MDL.

The FDA announced on Nov. 7 that it was considering removing phenylephrine as an ingredient in over-the-counter oral cold medications.